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To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Ultra | Experimental | Systane Ultra 1 drop each eye one time |
|
| Systane | Active Comparator | Systane 1 drop each eye one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra Lubricant Eye Drops | Other | Systane Ultra Lubricant Eye Drops 1 drop each eye one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drop Comfort | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable, | once upon instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Location | Fort Worth | Texas | 76134 | United States |
Randomized, double-masked, cross-over design
20 dry eye subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Ultra Drops, Then Systane Drops | Patients received Systane Ultra Drops first, then received Systane Drops. |
| FG001 | Systane Drops, Then Systane Ultra Drops | Patients first received Systane Drops, then received Systane Ultra Drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drop Comfort | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable, | Posted | Median | Standard Deviation | Units on a scale | once upon instillation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Systane Ultra | Systane Ultra |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Systane Lubricant Eye Drops | Other | Systane Lubricant Eye Drops 1 drop each eye one time |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Systane | Systane | 0 | 20 | 0 | 20 |
The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon reserves the right of prior review of any publication or presentation of information related to the study.